FDA 510(k)

ECG PEN

K-Number: K103077 · 2011-07-13

ApplicantMeridian Dynamics Biomedical, Inc.

Decision Date2011-07-13

Product CodeDPS

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

ECG PEN is the device name listed in this FDA 510(k) record. The listed applicant is Meridian Dynamics Biomedical, Inc.. It received FDA 510(k) clearance on 2011-07-13 under 510(k) number K103077. The device is classified under product code DPS. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ECG PEN?

ECG PEN is a medical device that received FDA 510(k) clearance on 2011-07-13. The listed applicant is Meridian Dynamics Biomedical, Inc.. The 510(k) number is K103077.

When did ECG PEN receive FDA 510(k) clearance?

ECG PEN received FDA 510(k) clearance on 2011-07-13, under 510(k) number K103077.

Who is the listed applicant for ECG PEN?

The FDA 510(k) record lists Meridian Dynamics Biomedical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ECG PEN?

The FDA product code for ECG PEN is DPS.

Related Devices (Code: DPS)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K254255S-Patch CardioAIWellysis Corp.K252463SE-1202 Series Electrocardiograph (Model: SE-1202, SE-1202E)Edan Instruments, Inc.K251670MAC 7 Resting ECG Analysis SystemGe Medical Systems Information Technologies, Inc.K252361AccurECG Analysis System (v2.0)Accurkardia, Inc.K252474Withings BeamO (SCT02)Withings K250569Cardiologs Holter PlatformPhilips France Commercial

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.